Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

130 results for "GC America, Inc."
1–24 of 130
Search insights Median review: 78d Cleared: 100% Top manufacturer: GC America, Inc. Lead specialty: Dental
Cleared Sep 10, 2026
Cerasmart Forte
K262202 · EBF
GC America, Inc.
Dental · 73d
Cleared Jul 06, 2026
Cytrans™ Elashield
K253317 · LYC
GC America, Inc.
Dental · 279d
Cleared Jun 18, 2026
SRGC-06
K261246 · EBF
GC America, Inc.
Dental · 63d
Cleared May 18, 2026
G-CEM UNIVERSAL
K254109 · EMA
GC America, Inc.
Dental · 150d
Cleared Oct 02, 2025
G-Bond Universal
K251124 · KLE
GC America, Inc.
Dental · 174d
Cleared Sep 19, 2025
EQUIA LC ONE
K250953 · EMA
GC America, Inc.
Dental · 175d
Cleared Aug 29, 2025
G aenial Universal Injectable II
K251946 · EBF
GC America, Inc.
Dental · 65d
Cleared Nov 24, 2020
G-CEM ONE
K200798 · EMA
GC America, Inc.
Dental · 243d
Cleared Oct 02, 2020
BZF-29
K200682 · KLE
GC America, Inc.
Dental · 200d
Cleared Aug 17, 2020
Cytrans Granules
K192597 · LYC
GC America, Inc.
Dental · 332d
Cleared Jul 09, 2020
GC Temp Print
K193113 · EBG
GC America, Inc.
Dental · 240d
Cleared Jul 02, 2020
GC Fuji Triage EP
K193484 · EMA
GC America, Inc.
Dental · 198d
Cleared Nov 22, 2019
everX Flow
K192260 · EBF
GC America, Inc.
Dental · 93d
Cleared Jul 11, 2019
GC FujiCEM 2 (Improved)
K182854 · EMA
GC America, Inc.
Dental · 274d
Cleared Nov 20, 2018
GC Acrylic Primer
K180917 · KLE
GC America, Inc.
Dental · 225d
Cleared Jul 12, 2018
AIM2
K181011 · ELW
GC America, Inc.
Dental · 86d
Cleared Apr 02, 2018
GC Fuji Direct
K172382 · EMA
GC America, Inc.
Dental · 237d
Cleared Mar 08, 2018
NMF004A
K173500 · EBF
GC America, Inc.
Dental · 115d
Cleared Sep 13, 2016
Initial LiSi Block
K153130 · EIH
GC America, Inc.
Dental · 319d
Cleared Jul 12, 2016
Gradia Plus
K153325 · EBF
GC America, Inc.
Dental · 236d
Cleared Jul 06, 2016
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
K153231 · EMA
GC America, Inc.
Dental · 240d
Cleared Jun 30, 2016
Initial LiSi Press
K153136 · EIH
GC America, Inc.
Dental · 244d
Cleared May 20, 2016
everX Posterior
K153127 · EBF
GC America, Inc.
Dental · 204d
Cleared Mar 25, 2016
MSCB-001
K152274 · EIH
GC America, Inc.
Dental · 226d